A Phase 1/2A Study of Minerval in Adult Patients With Advanced Solid Tumours

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1/2A, open label, non-randomized study in patients with advanced solid tumours including malignant glioma

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laminar Pharmaceuticals; Lipopharma Therapeutics SL
• Collaborators: Instituto Oncológico IMQ, Clínica IMQ Zorrotzaurre. Bilbao; Northern Institute for Cancer Research, Newcastle; Onkologikoa, San Sebastián.; Royal Marsden NHS Foundation Trust; Specialized Medical Services (SMS)-Oncology BV; Vall d'Hebron Institute of Oncology

Criteria

Inclusion Criteria

• Males or females providing written, informed consent

• Histologically- or cytologically-confirmed advanced solid malignancy that is refractory to standard-of-care treatment, or for which there is no standard therapy. If this is glioma:Grade III / Grade IV malignant glioma recurring or progressing after first or second line standard-of-care treatment and true progressive disease, confirmed according to the RANO criteria 4.

• Life-expectancy of at least 12 weeks

• Eastern cooperative oncology group (ECOG) performance status of 0-2

• Safety laboratory tests and ECGs within specified limits.

• Using adequate contraception, where applicable

• Presence of lesions suitable for biopsy (mandatory for non-glioma patients enrolled in the expanded safety cohort and highly desirable for non-glioma patients enrolled in the dose escalation phase)

Exclusion Criteria

• Anti cancer therapy within 4 weeks (6 weeks for mitomycin and nitrosureas and 2 weeks for palliative radiotherapy)

• NCI Common terminology criteria for adverse events (CTCAE) >Grade 1 toxicities from prior chemotherapy or radiotherapy that could impact on safety outcome assessment

• Recent >Grade 1 intracranial or intratumoural haemorrhage either by CT or MRI scan. Patients with resolving haemorrhage changes, punctuate haemorrhage or haemosiderin may enter the study

• Significant or uncontrolled cardiovascular disease, unstable angina or myocardial infarction within the preceding 6 months

• Known impairment of GI function that could alter the absorption of study drug

• History of uncontrolled hyperlipidemia and/or the need for concurrent lipid lowering therapy

• Concurrent severe and/or uncontrolled other medical disease that could compromise participation in the study

• Taking warfarin, phenytoin or sulphonylureas (glibenclamide, glimepiride, glipizide, glyburide or nateglanide)

• Pregnant or breast feeding Other protocol specific criteria may apply